Comparison of Two Pain-treatment Techniques After Cesarean Section

Michał Borys

Status and phase: Completed; Phase 4

Conditions: Cesarean Section; Neuropathic Pain; Pain Management

Treatments: Drug: Bupivacaine; Drug: Metamizol; Drug: Paracetamol; Procedure: QL (quadratus lumborum block); Drug: Morphine; Procedure: TAP (transversus abdominis plane block); Device: Needle; Drug: Ketoprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT02804126

KE-0254/85/2016

Details and patient eligibility

About

Comparison of two types of analgesia after cesarean section.

All patients will anaesthetised with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will measured with visual-analogue scale (VAS). 1, 2, 6 months after surgery each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).

Full description

Written consent will be obtained before the cesarean section. Only subarachnoidally anaesthetised patients may participate in the study. Pencil-point spinal needle and bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used.

At the end of surgery ultrasound-guided regional block will be performed. Each patient will be randomly allocated to one of the treated group: transversus abdominis plane block (TAP) or quadratus lumborum (QL). Patients receive 0.2 mL of local anesthetic solution (0.25 % bupivacaine) on each side.

Postoperative pain will be measured with VAS (visual-analogue scale) 2, 4, 8, 12 and 24 hours after the end of operation.

Paracetamol, metamizol, ketoprofen may be given as required. Whenever pain exceeds 40 (VAS) 5 mg of morphine will be given intravenously (maximum two dosages per day).

1, 3, 6 months patients will be called to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.

Enrollment: 232 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• obtained consent
• singleton pregnancy
• subarachnoid anaesthesia

Exclusion criteria

• coagulopathy
• allergy to to local anesthetics
• depression, antidepressant drugs treatment
• epilepsy
• usage of painkiller before surgery
• addiction to alcohol or recreational drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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232 participants in 2 patient groups

TAP (transversus abdominis plane)

Experimental group

Description:

Ultrasound-guided transversus abdominis plane block at the end of cesarean section

Treatment:

Drug: Metamizol

Drug: Paracetamol

Drug: Ketoprofen

Device: Needle

Drug: Morphine

Drug: Bupivacaine

Procedure: TAP (transversus abdominis plane block)

QL (quadratus lumborum)

Experimental group

Description:

Ultrasound-guided quadratus lumborum block at the end of cesarean section

Treatment:

Drug: Metamizol

Drug: Paracetamol

Drug: Ketoprofen

Device: Needle

Procedure: QL (quadratus lumborum block)

Drug: Morphine

Drug: Bupivacaine